In this podcast series sponsored by Biopharmaceutical Section of American Statistical Association, key opinion leaders from pharmaceutical industry and regulatory agencies talk about upcoming statistical conferences and events, and discuss current issues in Biopharmaceutical statistics.
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Ian describes how to leverage ChatGPT to accelerate statistical programming in the medical product industry. Related paper available here: https://www.pharmasug.org/proceedings/2024/AP/PharmaSUG-2024-AP-256.pdfPar American Statistical Association (ASA) Biopharm. Section
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Elaine Hoffman, Rebbecca Wilson, Christina Nurse, and Amy LaLonde discuss the balancing act between family and career.Par American Statistical Association (ASA) Biopharm. Section
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Episode 107: SPAIG Committee
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27:32
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Scott Clark, Satrajit Roychoudhury, and Michelle Shardell discuss the Statistical Partnerships Among Academe, Industry & Government (SPAIG) Committee. https://community.amstat.org/spaig/homePar American Statistical Association (ASA) Biopharm. Section
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Episode 106: Rebbecca Wilson
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Amy welcomes Rebbecca to the co-hosting chair while Christina enjoys some time off with her new baby (congrats)! The two discuss Rebbecca’s fascinating career thus far and how communication styles differ across male and female leaders. Reference: https://hbr.org/2022/12/research-men-speak-more-abstractly-than-women…
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Episode 105: Adrian Coles and Wendy Martinez
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43:59
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Adrian and Wendy discuss imposter syndrome and being confident in your career.Par American Statistical Association (ASA) Biopharm. Section
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Episode 104: Steve Ruberg
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1:01:33
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In our first episode of the new year, we interview Steve Ruberg, an ASA fellow with over 35 years of experience in the biopharmaceutical industry and an active proponent of the Tripartite Estimand Approach.Par American Statistical Association (ASA) Biopharm. Section
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Tian discusses her research in data integration methods and the bias arising from lack of representation.Par American Statistical Association (ASA) Biopharm. Section
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Episode 102: LaShell Robinson
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36:45
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36:45
LaShell discusses diversity, equity, and inclusion in clinical trials.Par American Statistical Association (ASA) Biopharm. Section
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Episode 101: Elizabeth Mannshardt-Hawk on Imposter Syndrome
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45:48
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45:48
Elizabeth discusses imposter syndrome and how to manage it in your statistical career. In collaboration with the ASA's Committee on Career Development (CCD website) .Par American Statistical Association (ASA) Biopharm. Section
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Episode 100: Dionne Price, ASA President-Elect
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Dionne talks about her journey in biostatistics and her goals for the ASA when she becomes President in 2023.Par American Statistical Association (ASA) Biopharm. Section
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Episode 99: Amy LaLonde and Christina Nurse
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33:46
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33:46
This episode introduces new podcast cohosts Amy LaLonde and Christina Nurse! They take over hosting duties starting with Episode 101.Par American Statistical Association (ASA) Biopharm. Section
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Episode 98: Safety Scientific Working Group
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53:45
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53:45
James Buchanan, Judy Li, Melvin Munsaka, and Bill Wang discuss the research of the Safety Scientific Working Group and their recent edited volume "Quantitative Drug Safety and Benefit Risk Evaluation: Practical and Cross-Disciplinary Approaches." https://tinyurl.com/2ucyer95Par American Statistical Association (ASA) Biopharm. Section
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Episode 97 - Devan Mehrotra
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49:11
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49:11
Devan discusses the 5-STAR methodology and endpoints for COVID vaccine clinical trials.Par American Statistical Association (ASA) Biopharm. Section
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Alan is the 2022 Chair of the Biopharmaceutical Section. He discusses his wish list for things to accomplish this year.Par American Statistical Association (ASA) Biopharm. Section
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Anna Nevius reflects on her time at the Center for Veterinary Medicine at the FDA and as chair of the Biopharmaceutical Section in 2009.Par American Statistical Association (ASA) Biopharm. Section
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Bob Starbuck reflects on his time as chair of the Biopharmaceutical Section in 1994.Par American Statistical Association (ASA) Biopharm. Section
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Episode 93: External Control Arms
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53:53
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53:53
Amy Xia and Lanju Zhang discuss the benefits and challenges of utilizing external control arms for clinical trials.Par American Statistical Association (ASA) Biopharm. Section
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Episode 92: 2021 Regulatory-Industry Statistics Workshop
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35:51
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35:51
Bo Huang and Gene Pennello discuss the 2021 Regulatory-Industry Statistics Workshop.Par American Statistical Association (ASA) Biopharm. Section
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Episode 91: Patient Reported Outcomes
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1:02:04
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1:02:04
Joseph Cappelleri and Daniel O’Connor discuss the benefits and challenges in using patient reported outcomes and how to appropriately define clinically-meaningful change.Par American Statistical Association (ASA) Biopharm. Section
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Episode 90: ICSA Leadership Panel
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31:38
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31:38
Haoda Fu, Mengling Liu, Jie Tang, Tian Zheng, and Kelly Zou discuss leadership and the impact of COVID-19 on the workplace.Par American Statistical Association (ASA) Biopharm. Section
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Karl Peace was chair of the Biopharmaceutical Section in 1990. He discusses his career in the industry, the Jiann-Ping Hsu College of Public Health, and the Biopharmaceutical Applied Statistics Symposium.Par American Statistical Association (ASA) Biopharm. Section
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Episode 88: Katherine Monti
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56:50
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56:50
Katherine Monti was chair of the Biopharmaceutical Section in 2010. She discusses her career in the industry and how the Section has changed over time.Par American Statistical Association (ASA) Biopharm. Section
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Episode 87: Storytelling
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1:04:59
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1:04:59
Scott Evans, Stephanie Omokaro, Janet Wittes, and Zhiheng Xu discuss the importance of storytelling for the modern statistician.Par American Statistical Association (ASA) Biopharm. Section
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Episode 86: Pediatric Drug Development Scientific Working Group
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47:09
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47:09
Meg Gamalo and Jingjing Ye talk about pediatric drug development and discuss why forming a scientific working group was so important.Par American Statistical Association (ASA) Biopharm. Section
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Weili talks about publishing, leadership, and her hopes and plans for the Biopharmaceutical Section in 2021.Par American Statistical Association (ASA) Biopharm. Section
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